A Double Blind Study Comparing Hyaluronic Acid, Corticosteroid and Placebo During Arthrocentesis for TMJ
This study is currently recruiting participants.
Verified March 2012 by Emory University
Sponsor:
Emory University
Collaborators:
University of California, Los Angeles
Oregon Health and Science University
University of Minnesota - Clinical and Translational Science Institute
University of Cincinnati
University of Pennsylvania
Information provided by (Responsible Party):
Gary F Bouloux MD, DDS, MDSc, FRACDS, FRACDS, Emory University
ClinicalTrials.gov Identifier:
NCT01524913
First received: January 29, 2012
Last updated: November 6, 2012
Last verified: March 2012
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Purpose
The purpose of this study is to determine whether the administration of hyaluronic acid or corticosteroid during arthrocentesis of the temporomandibular joint provides additional pain relief and improved function.
The overall hypothesis for the study is that hyalgan will result in a 30% reduction in the mean visual analogue scale (VAS) at one month when compared to celestone and placebo.
| Condition | Intervention | Phase |
|---|---|---|
|
Temporomandibular Joint Dysfunction Pain Arthrocentesis |
Drug: Hyaluronic acid Drug: Corticosteroid Drug: Lactated Ringers |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Double Blind Randomised Study Comparing Hyaluronic Acid, Corticosteroid and Placebo During Arthrocentesis for Temporomandibular Joint Dysfunction |
Resource links provided by NLM:
Further study details as provided by Emory University:
Primary Outcome Measures:
- Pain [ Time Frame: 3 months ] [ Designated as safety issue: No ]Pain will be assessed preoperatively and again at 1 and 3 months using a visual analogue scale
Secondary Outcome Measures:
- Function [ Time Frame: 3 months ] [ Designated as safety issue: No ]Range of motion will be assessed preoperatively and again at 1 and 3 months using a millimeter ruler for maximum incisal opening and a jaw function limitation scale for other functional activities
| Estimated Enrollment: | 330 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Hyaluronic acid |
Drug: Hyaluronic acid
1 cc hyalgan to be injected into superior joint space
|
| Active Comparator: Corticosteroid |
Drug: Corticosteroid
1cc celestone (6 mg/cc) will be injected into the joint space
|
| Placebo Comparator: Saline |
Drug: Lactated Ringers
1 cc lactated ringers solution will be injected into the joint space
|
Detailed Description:
This study will enroll patients with temporomandibular joint dysfunction who are deemed appropriate candidates for irrigation of their jaw joints secondary to pain or limited opening. At the completion of the joint irrigation subjects will be injected by one of three different products to determine if the additional injection results in a further decrease in jaw joint pain and improved opening. Subjects will be followed for 3 months. Those who do not show improvement may be candidates for additional treatment.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- age greater than 18 years
- arthralgia of one or both temporomandibular joints
- Wilkes II to IV internal derangement of the symptomatic joint OR
- limited opening of <35 mm
Exclusion Criteria:
myofascial pain as the primary source of pain
- cervical pain as the primary source of pain
- systemic arthropathy
- fibromyalgia
- use of NSAIDS within 48 hours
- allergy to study medications
- edentulous subjects
- pregnancy or breast feeding
- current physical therapy, muscle relaxants or antiseizure medications
- current use of a splint issued within last 12 weeks
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01524913
Contacts
| Contact: Gary Bouloux, MD, DDS | 404 778 4555 | gfboulo@emory.edu |
Locations
| United States, California | |
| University California Los Angeles | Recruiting |
| Los Angeles, California, United States, 90024 | |
| Contact: Tara Agahloo, MD, DDS | |
| Principal Investigator: Tara Aghaloo, MD, DDS | |
| Sub-Investigator: Alan Felsenfeld, DDS | |
| Sub-Investigator: Nora Kahenasa, DDS | |
| United States, Georgia | |
| Emory University | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Gary Bouloux, MD, DDS 404-778-4555 gfboulo@emory.edu | |
| Sub-Investigator: Martin Steed, DDS | |
| Sub-Investigator: Steven Roser, DMD, MD | |
| United States, Minnesota | |
| University of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Pamela Hughes, MD, DDS | |
| Sub-Investigator: Deepak Kademani, MD, DDS | |
| Sub-Investigator: James Swift, DDS | |
| United States, Ohio | |
| University of Cinncinati | Not yet recruiting |
| Cinncinati, Ohio, United States, 45219 | |
| Contact: Deepak Krishnan, BDS | |
| Sub-Investigator: Robert Marciani, DMD | |
| United States, Oregon | |
| Oregon Health Sciences University | Recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: Julie Smith, MD, DDS | |
| Sub-Investigator: Leon Assael, DMD | |
| Sub-Investigator: Robert Myall, BDS, MD | |
| United States, Pennsylvania | |
| University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Joli Choi, MD, DDS | |
| Sub-Investigator: Helen Giannakopoulos, MD, DDS | |
Sponsors and Collaborators
Emory University
University of California, Los Angeles
Oregon Health and Science University
University of Minnesota - Clinical and Translational Science Institute
University of Cincinnati
University of Pennsylvania
Investigators
| Principal Investigator: | Gary F Bouloux, MD, DDS | Emory University |
More Information
No publications provided
| Responsible Party: | Gary F Bouloux MD, DDS, MDSc, FRACDS, FRACDS, National PI, Emory University |
| ClinicalTrials.gov Identifier: | NCT01524913 History of Changes |
| Other Study ID Numbers: | Arthrocentesis |
| Study First Received: | January 29, 2012 |
| Last Updated: | November 6, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Joint Diseases Temporomandibular Joint Disorders Temporomandibular Joint Dysfunction Syndrome Musculoskeletal Diseases Craniomandibular Disorders Mandibular Diseases Jaw Diseases Muscular Diseases |
Stomatognathic Diseases Myofascial Pain Syndromes Hyaluronic Acid Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013